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Pemetrexed versus erlotinib in pretreated patients with advanced non–small cell lung cancer: A Hellenic Oncology Research Group (HORG) randomized phase 3 study
Author(s) -
Karampeazis Athanasios,
Voutsina Alexandra,
Souglakos John,
Kentepozidis Nikos,
Giassas Stelios,
Christofillakis Charalambos,
Kotsakis Athanasios,
Papakotoulas Pavlos,
Rapti Ageliki,
Agelidou Maria,
Agelaki Sofia,
Vamvakas Lambros,
Samonis George,
Mavroudis Dimitris,
Georgoulias Vassilis
Publication year - 2013
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.28132
Subject(s) - pemetrexed , medicine , erlotinib , lung cancer , oncology , phases of clinical research , randomized controlled trial , erlotinib hydrochloride , cancer , chemotherapy , cisplatin , epidermal growth factor receptor
BACKGROUND In this superiority study, pemetrexed was compared with erlotinib in pre‐treated patients with metastatic non–small cell lung cancer (NSCLC). METHODS Patients with stage IIIB/IV NSCLC who progressed after first‐line or second‐line treatment were randomized to receive either pemetrexed or erlotinib. In total, 21.7% of patients in the pemetrexed arm and 23.5% of patients in the erlotinib arm had squamous cell histology, and treatment was third line in 39.2% and 46.4% of patients, respectively. The primary study endpoint was time to tumor progression (TTP). Epidermal growth factor receptor/v‐Ki‐ ras 2 Kirsten rat sarcoma viral oncogene homolog ( EGFR / KRAS ) mutation status also was investigated. RESULTS There was no difference in terms of the TTP ( P = .195), the objective response rate ( P = .469), or overall survival ( P = .986) between the 2 treatment arms. In patients who had squamous cell histology, erlotinib resulted in a superior TTP compared with pemetrexed (4.1 months vs 2.5 months, respectively; P = .006). The incidence of grade 3 and 4 neutropenia, thrombocytopenia, and asthenia was significantly higher in the pemetrexed arm, whereas the incidence of grade 3 and 4 skin rash was higher in the erlotinib arm. CONCLUSIONS Both pemetrexed and erlotinib had comparable efficacy in pre‐treated patients with metastatic NSCLC, and the current results indicated that genotyping of tumor cells may have an important effect on treatment efficacy. Cancer 2013 ;119:2754–2764. © 2013 American Cancer Society .